Hepatitis C
Conditions
Brief summary
The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate.
Interventions
DRUGDaclatasvir
Tablet, Oral, 60 mg, once daily, 24 weeks
Syringe, Subcutaneous Injection, 180 μg, Once weekly, 24 or 48 weeks depending on response
DRUGRibavirin
Tablet, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 or 48 weeks depending on response
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants chronically infected with Hepatitis C virus (HCV) genotype 1 * HCV RNA viral load of ≥10,000 IU/mL at screening * No previous exposure to interferon formulation, ribavirin or HCV direct antiviral agent * Self-described as Black-African American, Latino or White-Caucasian * Results of a liver biopsy obtained ≤36 months prior to first treatment compensated cirrhotics with HCV liver biopsy from any time prior to first treatment. Compensated cirrhotics were capped at approximately 25%
Exclusion criteria
* Evidence of decompensated liver disease * Documented or suspected Hepatocellular carcinoma (HCC) * Positive for Hepatitis B or HIV 1/HIV 2 antibody at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) | Post-treatment Week 12 | SVR12 was defined as Hepatitis C Virus (HCV) RNA levels \<lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene | Post-treatment Week 12 | SVR12 was defined as Hepatitis C Virus (HCV) RNA levels \<lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort. |
| Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Week 24 | The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. Data for post-treatment Weeks 36 and 48 were based on participants who had achieved virologic response (defined as HCV RNA levels \<LLOQ, target not detected) at both Weeks 4 and 12, and completed 24 weeks of study treatment. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort. |
| Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Weeks 12 and 24 | The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort. |
| Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | From first dose to last dose plus 7 days (treatment period [TP]) through 48 weeks after the end of TP (follow-up period [FUP]) | An AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. For analysis purpose, participants were assigned to following 4 race/ethnicity cohorts: Black/African American, White/Caucasian, Latino and Non-Latino. Some participants were represented in more than one race/ethnicity cohort. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
The study was conducted at 33 clinical sites in United States.
Pre-assignment details
A total of 448 participants were enrolled, and 246 entered treatment period. Remaining 202 did not enter treatment period (29: withdrew consent, 17: lost to follow-up, 156: no longer met study criteria). As per protocol, any participant who discontinued the treatment period was still expected to enter the post-treatment follow-up period.
Participants by arm
| Arm | Count |
|---|---|
| Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events. | 246 |
| Total | 246 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Follow-up Period (up to 48 Weeks) | Follow-up no longer needed per protocol | 2 |
| Follow-up Period (up to 48 Weeks) | Lost to Follow-up | 22 |
| Follow-up Period (up to 48 Weeks) | Other | 3 |
| Follow-up Period (up to 48 Weeks) | Withdrawal by Subject | 10 |
| Treatment Period (up to 48 Weeks) | Adverse Event | 24 |
| Treatment Period (up to 48 Weeks) | Did not meet study criteria | 2 |
| Treatment Period (up to 48 Weeks) | Lack of Efficacy | 41 |
| Treatment Period (up to 48 Weeks) | Lost to Follow-up | 10 |
| Treatment Period (up to 48 Weeks) | Participant's request to discontinue | 6 |
| Treatment Period (up to 48 Weeks) | Poor/non-compliance | 5 |
| Treatment Period (up to 48 Weeks) | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin |
|---|---|
| Age, Continuous | 51.8 years STANDARD_DEVIATION 9.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 107 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 139 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hepatitis C Virus Genotype Subtype 1 | 1 participants |
| Hepatitis C Virus Genotype Subtype 1A | 191 participants |
| Hepatitis C Virus Genotype Subtype 1B | 54 participants |
| Hepatitis C Virus RNA Distribution <800,000 IU/mL | 64 participants |
| Hepatitis C Virus RNA Distribution ≥800,000 IU/mL | 182 participants |
| Hepatitis C Virus RNA Levels | 6.21 Log10 IU/mL STANDARD_DEVIATION 0.684 |
| Race/Ethnicity, Customized Black/African American Latino | 19 participants |
| Race/Ethnicity, Customized Black/African American Non-Latino | 109 participants |
| Race/Ethnicity, Customized White/Caucasian Non-Latino | 30 participants |
| Race/Ethnicity, Customized White Latino | 88 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 128 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 118 Participants |
| rs12979860 Single Nucleotide Polymorphism in the Interleukin-28B Gene Heterozygous (CT) | 134 participants |
| rs12979860 Single Nucleotide Polymorphism in the Interleukin-28B Gene Minor Homozygous (TT) | 62 participants |
| rs12979860 Single Nucleotide Polymorphism in the Interleukin-28B Gene Wild Type (CC) | 50 participants |
| Sex: Female, Male Female | 69 Participants |
| Sex: Female, Male Male | 177 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 227 / 246 |
| serious Total, serious adverse events | 21 / 246 |
Outcome results
Primary
Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12)
SVR12 was defined as Hepatitis C Virus (HCV) RNA levels \<lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.
Time frame: Post-treatment Week 12
Population: All treated participants. Modified intent-to-treat analysis (participants meeting the response criteria / all treated participants) was performed for Black/African American and Latino cohorts.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Black/African American Cohort | Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) | 50.8 percentage of participants |
| Latino Cohort | Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) | 57.0 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) | 66.7 percentage of participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died
An AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. For analysis purpose, participants were assigned to following 4 race/ethnicity cohorts: Black/African American, White/Caucasian, Latino and Non-Latino. Some participants were represented in more than one race/ethnicity cohort.
Time frame: From first dose to last dose plus 7 days (treatment period [TP]) through 48 weeks after the end of TP (follow-up period [FUP])
Population: All treated participants for TP and all follow-up participants for FUP. Here, n signifies the number of participants evaluable in their respective study periods.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Black/African American Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | SAEs: TP (n=128,118,107,139,246) | 12 participants |
| Black/African American Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | Discontinued due to AE: TP (n=128,118,107,139,246) | 9 participants |
| Black/African American Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | Treatment-related AEs: TP (n=128,118,107,139,246) | 111 participants |
| Black/African American Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | Deaths: TP (n=128,118,107,139,246) | 0 participants |
| Black/African American Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | SAEs: FUP (n=117,104,96,125,221) | 3 participants |
| Black/African American Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | Deaths: FUP (n=117,104,96,125,221) | 0 participants |
| Latino Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | SAEs: FUP (n=117,104,96,125,221) | 0 participants |
| Latino Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | Deaths: FUP (n=117,104,96,125,221) | 0 participants |
| Latino Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | SAEs: TP (n=128,118,107,139,246) | 9 participants |
| Latino Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | Treatment-related AEs: TP (n=128,118,107,139,246) | 108 participants |
| Latino Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | Deaths: TP (n=128,118,107,139,246) | 0 participants |
| Latino Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | Discontinued due to AE: TP (n=128,118,107,139,246) | 15 participants |
| White Non-Latino Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | Deaths: TP (n=128,118,107,139,246) | 0 participants |
| White Non-Latino Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | SAEs: FUP (n=117,104,96,125,221) | 1 participants |
| White Non-Latino Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | SAEs: TP (n=128,118,107,139,246) | 5 participants |
| White Non-Latino Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | Treatment-related AEs: TP (n=128,118,107,139,246) | 93 participants |
| White Non-Latino Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | Discontinued due to AE: TP (n=128,118,107,139,246) | 6 participants |
| White Non-Latino Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | Deaths: FUP (n=117,104,96,125,221) | 0 participants |
| Non-Latino Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | Deaths: TP (n=128,118,107,139,246) | 0 participants |
| Non-Latino Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | Discontinued due to AE: TP (n=128,118,107,139,246) | 18 participants |
| Non-Latino Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | Treatment-related AEs: TP (n=128,118,107,139,246) | 126 participants |
| Non-Latino Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | Deaths: FUP (n=117,104,96,125,221) | 0 participants |
| Non-Latino Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | SAEs: FUP (n=117,104,96,125,221) | 2 participants |
| Non-Latino Cohort | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | SAEs: TP (n=128,118,107,139,246) | 16 participants |
| Overall Population | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | SAEs: FUP (n=117,104,96,125,221) | 3 participants |
| Overall Population | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | Treatment-related AEs: TP (n=128,118,107,139,246) | 219 participants |
| Overall Population | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | Discontinued due to AE: TP (n=128,118,107,139,246) | 24 participants |
| Overall Population | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | Deaths: FUP (n=117,104,96,125,221) | 0 participants |
| Overall Population | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | Deaths: TP (n=128,118,107,139,246) | 0 participants |
| Overall Population | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | SAEs: TP (n=128,118,107,139,246) | 21 participants |
Secondary
Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene
SVR12 was defined as Hepatitis C Virus (HCV) RNA levels \<lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.
Time frame: Post-treatment Week 12
Population: All treated participants. Here, 'n' signifies the number of participants evaluable in the specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Black/African American Cohort | Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene | Heterozygous (CT) (n=58, 69, 17) | 53.4 percentage of participants |
| Black/African American Cohort | Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene | Wild Type (CC) (n=20, 24, 10) | 80.0 percentage of participants |
| Black/African American Cohort | Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene | Minor Homozygous (TT) (n=50, 14, 3) | 36.0 percentage of participants |
| Latino Cohort | Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene | Heterozygous (CT) (n=58, 69, 17) | 50.7 percentage of participants |
| Latino Cohort | Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene | Wild Type (CC) (n=20, 24, 10) | 70.8 percentage of participants |
| Latino Cohort | Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene | Minor Homozygous (TT) (n=50, 14, 3) | 64.3 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene | Wild Type (CC) (n=20, 24, 10) | 80.0 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene | Minor Homozygous (TT) (n=50, 14, 3) | 66.7 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene | Heterozygous (CT) (n=58, 69, 17) | 58.8 percentage of participants |
Secondary
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points
The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. Data for post-treatment Weeks 36 and 48 were based on participants who had achieved virologic response (defined as HCV RNA levels \<LLOQ, target not detected) at both Weeks 4 and 12, and completed 24 weeks of study treatment. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.
Time frame: Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Week 24
Population: All treated participants. Here, 'N' (number of participants analyzed) signifies number of participants evaluable at the specified time-points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Black/African American Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Week 6 | 76.6 percentage of participants |
| Black/African American Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Post-treatment Week 24 | 46.9 percentage of participants |
| Black/African American Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Week 12 | 71.1 percentage of participants |
| Black/African American Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Week 8 | 76.6 percentage of participants |
| Black/African American Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Week 1 | 32.8 percentage of participants |
| Black/African American Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | EOT | 73.4 percentage of participants |
| Black/African American Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Week 4 | 77.3 percentage of participants |
| Black/African American Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Week 2 | 64.1 percentage of participants |
| Black/African American Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Both Weeks 4 and 12 | 68.0 percentage of participants |
| Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Week 8 | 81.3 percentage of participants |
| Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Week 1 | 44.9 percentage of participants |
| Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Week 2 | 72.0 percentage of participants |
| Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Week 4 | 85.0 percentage of participants |
| Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Week 6 | 81.3 percentage of participants |
| Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Week 12 | 80.4 percentage of participants |
| Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Both Weeks 4 and 12 | 77.6 percentage of participants |
| Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | EOT | 79.4 percentage of participants |
| Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Post-treatment Week 24 | 57.0 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Week 4 | 66.7 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Week 1 | 33.3 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Both Weeks 4 and 12 | 56.7 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Week 2 | 60.0 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Post-treatment Week 24 | 63.3 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Week 8 | 76.7 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Week 6 | 80.0 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | EOT | 93.3 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | Week 12 | 76.7 percentage of participants |
Secondary
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points
The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.
Time frame: Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Weeks 12 and 24
Population: All treated participants. Here, 'N' (number of participants analyzed) signifies number of participants evaluable at the specified time-points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Black/African American Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Week 1 | 6.3 percentage of participants |
| Black/African American Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Week 2 | 28.1 percentage of participants |
| Black/African American Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Week 4 | 64.1 percentage of participants |
| Black/African American Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Week 6 | 68.8 percentage of participants |
| Black/African American Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Week 8 | 70.3 percentage of participants |
| Black/African American Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Week 12 | 64.1 percentage of participants |
| Black/African American Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Both Weeks 4 and 12 | 55.5 percentage of participants |
| Black/African American Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | EOT | 71.1 percentage of participants |
| Black/African American Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Post-treatment Week 12 | 50.8 percentage of participants |
| Black/African American Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Post-treatment Week 24 | 46.9 percentage of participants |
| Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Post-treatment Week 12 | 55.1 percentage of participants |
| Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Week 1 | 12.1 percentage of participants |
| Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Week 12 | 74.8 percentage of participants |
| Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Week 8 | 73.8 percentage of participants |
| Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Week 2 | 27.1 percentage of participants |
| Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Post-treatment Week 24 | 55.1 percentage of participants |
| Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | EOT | 78.5 percentage of participants |
| Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Week 4 | 68.2 percentage of participants |
| Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Both Weeks 4 and 12 | 58.9 percentage of participants |
| Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Week 6 | 75.7 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | EOT | 93.3 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Week 6 | 66.7 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Week 8 | 66.7 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Week 12 | 66.7 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Post-treatment Week 12 | 63.3 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Both Weeks 4 and 12 | 43.3 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Week 1 | 6.7 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Post-treatment Week 24 | 63.3 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Week 2 | 30.0 percentage of participants |
| White Non-Latino Cohort | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | Week 4 | 50.0 percentage of participants |